Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers.
1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7.
2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8.
3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1596-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers.
1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9.
2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1597-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers.
1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9.
2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9.
3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8.
4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9.
5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13.
6. Straight Plate, 3.5mm; Article Number: 21102-6.
7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1598-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
I.T.S. Screw System with the below descriptions and corresponding article numbers.
1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95.
2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70.
3. Washer; Article Number: 36851.
4. Washer, Concave; Article Numbers: 36432, 36653, 36732.
5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Screw, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1599-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers.
1. Fixation Screw; Article Number: 70312.
2. Spike short; Article Number: 70314.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1600-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers.
1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8.
2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12.
3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1601-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers.
1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N.
2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1602-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers.
1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13.
2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12.
3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1603-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers.
1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4.
2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6.
3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1604-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers.
1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30.
2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34.
3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24.
4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6.
5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME.
6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483.
7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5.
8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30.
9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1605-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Screw, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1606-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers.
1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20.
2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4.
3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4.
4. HLS Plate, Square; Article Numbers: 21517.
5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10.
6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5.
7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Root cause: No Marketing Application
Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1607-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers.
1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16.
2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14.
3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12.
4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90.
5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90.
6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200.
7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32.
8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90.
9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20.
10. Posterior Column Plate, Left; Article Numbers: 212121-6.
11. Posterior Column Plate, Right; Article Numbers: 212131-6.
12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM.
13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA.
14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM.
15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8.
16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8.
17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7.
18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13.
19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11.
20. Rim Plate, Left; Article
Open, ClassifiedPosted Mar 20, 2026·Initiated Jul 24, 2025
MicroScan Neg MIC 56 REF C42464
UDI-DI code: 15099590731212
MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Reason: Due to the likely presence of contamination in well(s).
Root cause: Material/Component Contamination
Recalling firm: Beckman Coulter, Inc.Type: Panels, Test, Susceptibility, AntimicrobialDistribution: U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.Recall #Z-1609-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 12, 2026
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Root cause: Reprocessing Controls
Recalling firm: Olympus Corporation of the AmericasType: Endoscope Channel AccessoryDistribution: US Nationwide distribution.Recall #Z-1610-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 12, 2026
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Root cause: Reprocessing Controls
Recalling firm: Olympus Corporation of the AmericasType: Endoscope Channel AccessoryDistribution: US Nationwide distribution.Recall #Z-1611-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 12, 2026
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Root cause: Reprocessing Controls
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: US Nationwide distribution.Recall #Z-1612-2026
Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 12, 2026
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Root cause: Reprocessing Controls
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: US Nationwide distribution.Recall #Z-1613-2026
Open, ClassifiedPosted Mar 19, 2026·Initiated Feb 10, 2026
Artegraft Vascular Graft;
REF#: AG740;
Reason: Labeling mix-up resulting in the incorrect lot outer packaging of product.
Root cause: Labeling Change Control
Recalling firm: LeMaitre Vascular, Inc.Type: Tissue Graft Of 6mm And GreaterDistribution: US Nationwide distribution in the state of IL.Recall #Z-1574-2026
Open, ClassifiedPosted Mar 19, 2026·Initiated Feb 18, 2026
Cub Pediatric Crib, Model FL19H
Reason: Cribs sold in the USA are missing two access door warning labels.
Root cause: Under Investigation by firm
Recalling firm: Stryker Medical Division of Stryker CorporationType: Bed, Pediatric Open HospitalDistribution: US Nationwide distribution.Recall #Z-1580-2026