Product category · Updated Aug 19, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 41,070 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
41,070 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-04
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 798 of 822
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software up…
Biomerieux Inc
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage:…
King Systems Corp.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Sof…
Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 So…
Biomerieux Inc
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffus…
Superstat Corp
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provision…
Zimmer, Inc.
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare, LLC
bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Softw…
Biomerieux Inc
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimen…
Biomerieux Inc
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundari…
Mako Surgical Corporation
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare, LLC
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: Th…
Biomet, Inc.
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20…
King Systems Corp.
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in…
Beckman Coulter Inc.
Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head …
Zimmer, Inc.
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance…
Innovative Magnetic Resonance Imaging Systems Inc.
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, ca…
Biomerieux Inc
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumb…
KCI USA, Inc.
GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare, LLC
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, …
Superstat Corp
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device u…
Mindray DS USA, Inc. d.b.a. Mindray North America
bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the cli…
Biomerieux Inc
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects…
Stryker Howmedica Osteonics Corp.
Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www…
Stryker Spine
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, cat…
Biomerieux Inc
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
King Systems Corp.
Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture li…
Superstat Corp
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software upda…
Biomerieux Inc
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Produ…
King Systems Corp.
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in …
Superstat Corp
0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is anal…
Biomerieux Inc
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are …
Kerr Corporation
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provision…
Zimmer, Inc.
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, i…
Superstat Corp
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 S…
Biomerieux Inc
SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign…
Sentec AG
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means …
Biomet 3i, LLC
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects…
Stryker Howmedica Osteonics Corp.
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Gyrus Acmi, Incorporated
7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn …
Biomerieux Inc
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatmen…
Carl Zeiss Meditec, Inc.
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in …
Superstat Corp
7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Aug 19, 2026.