Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,235
Critical: 4
Severe: 260
Most recent: 2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

2101–2125 of 2235

ModerateFDA (Devices)·Z-2260-2013·2013-09-25
Integra Recalls Cranial Access Kits Due to Potential Sterile Seal Compromise
Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.
Product
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-996-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Selenium Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Selenium 400 mcg/mL injectable because FDA inspections raised concerns about quality control and sterility assurance.
Product
SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2189-2013·2013-09-18
Edwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error
Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.
Product
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2158-2013·2013-09-11
MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise
MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Product
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2159-2013·2013-09-11
MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals
MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Product
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2013·2013-09-04
Zimmer Free Lock Femoral Hip Fixation System Compression Lag Screw Recall
Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.
Product
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2013·2013-09-04
Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.
Product
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2013·2013-09-04
Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.
Product
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2013·2013-09-04
Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure
Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.
Product
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2013·2013-09-04
Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling 85,794 units of the Versa-FX II Femoral Fixation System because a packaging configuration failed leak tests, compromising product sterility.
Product
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1984-2013·2013-08-28
Medicel nanoPOINT Injector System Recalled for Potential Sterility Compromise
Medicel Ag is recalling one lot of nanoPOINT Injector Systems because damaged Tyvek lids may have compromised the sterile barrier.
Product
Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1983-2013·2013-08-28
Gyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure
Gyrus Medical is recalling 1,140 sterile bipolar dissecting forceps units because accelerated aging tests showed a compromised sterile packaging seal.
Product
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2013·2013-08-14
Nestle Compat Nasogastric Feeding Tubes Recalled for Sterility Concerns
Nestle HealthCare Nutrition is recalling 37,310 Compat Nasogastric Feeding Tubes because they were delivered in insufficiently sealed pouches, compromising their sterility.
Product
Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1772-2013·2013-07-31
Ethicon Recalls Endopath Electrosurgery Probes Due to Potential Sterility Compromise
Ethicon Endo-Surgery Inc is recalling 327,648 Endopath Electrosurgery Probe Plus II instruments because a tear in the Tyvek packaging may affect the sterility of the devices.
Product
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1728-2013·2013-07-24
Karl Storz Balloon Catheter Recalled for Potential Sterility Compromise
Karl Storz Endoscopy America is recalling 27023WU Balloon Catheters because packaging defects may compromise sterility. The recall affects 40 units distributed to five US states.
Product
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1682-2013·2013-07-17
Baxter Recalls Four Lead TUR Irrigation Sets Due to Packaging Pinholes
Baxter Healthcare is recalling 356,728 units of Four Lead TUR irrigation sets because pinholes in the packaging could compromise sterile barrier properties.
Product
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1684-2013·2013-07-17
Baxter Recalls Arthroscopic Irrigation Sets Due to Packaging Pinholes
Baxter Healthcare Corp. is recalling Four Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.
Product
Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1683-2013·2013-07-17
Baxter Arthroscopic Irrigation Sets Recalled Due to Packaging Pinholes
Baxter Healthcare is recalling Two Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.
Product
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1640-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Reprocessed Medical Devices
Surgical Instrument Service And Savings, Inc. is recalling 34 reprocessed medical devices because the sterile barrier seal became compromised, allowing product to fall out of the pouch.
Product
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1629-2013·2013-07-10
Surgical Instrument Service Recalls Re-New II Endocut Scissor Tips
Surgical Instrument Service and Savings, Inc. is recalling 10 Re-New II Endocut Scissor Tips because the sterile barrier seal is compromised, allowing the product to fall out of the pouch.
Product
- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1628-2013·2013-07-10
Surgical Instrument Service Recalls Arthroscopic Electrodes Due to Seal Compromise
Surgical Instrument Service and Savings, Inc. is recalling 447 units of arthroscopic electrodes and wands because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1639-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Relieva Flex Sinus Guide Catheter
Surgical Instrument Service And Savings, Inc. is recalling Relieva Flex Sinus Guide Catheter and Luma Sentry 20 Tip Angle products because the sterile barrier seal may be compromised.
Product
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1637-2013·2013-07-10
TPS Micro Reciprocating Rasp Recalled Due to Compromised Sterile Seal
Surgical Instrument Service And Savings, Inc. is recalling four units of TPS Micro Reciprocating Small Tear Cross Cut Rasps because the sterile barrier seal may be compromised.
Product
TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1627-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Scorpion Needles Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1632-2013·2013-07-10
Barron Radial Vacuum Trephine Set Recalled Due to Compromised Sterile Seal
Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine Sets because the sterile seal may be compromised, allowing product to fall out of the pouch.
Product
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
Category
Medical Device
Distribution
Distributed nationwide